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Regulatory Submissions / eCTD

Create and manage submission documentation leveraging information from our RIM module, and publishing via partner tools such as Lorenz docuBridge, with full traceability of “where used”.

The CARA configuration for submission documents is based on the DIA Reference Model, including all document artifacts and metadata, with some adjustments based on industry best practices. Create a Global Dossier and then regional derived dossiers, with re-use of content to ensure maximum efficiency of process.

The CARA RIM and IDMP modules extend the functionality to cover the submission planning, regulatory events, applications and registration. Publish through one of our partners, for example Lorenz docuBridge as part of the Alliance of Experts and archive back to CARA for viewing with tools like Dossplorer, also part of the Alliance of Experts.

CARA SUBMISSION FEATURES

  • Document classification and metadata based on the DIA Reference Model
  • Creation of content based on templates
  • Collaborative authoring – multiple users simultaneously
  • Review and approval of content including eSignature
  • Create submission structure in CARA and assign content
  • Drag and drop CARA structures or individual documents to publishing tools
  • Build submission structures automatically from submission planning tools in CARA (RIM module) or partner tools e.g. drugTrack and docuBridge from Lorenz
  • Archive submissions from publishing tools to CARA, including automatic traceability to the source components used for publishing
  • View submissions from CARA using partner tools such as Dossplorer
  • Manage Master Data in CARA IDMP module, or pull in from external tools to use on document metadata

CARA benefits

Maximise the user experience
simple to learn and use and personalised to each individual’s requirements

Access and manage content from one place
a single destination user interface, integrated seamlessly with multiple systems

Meet corporate and regulatory standards
configure CARA to suit your exact requirements

Supports the full document lifecycle
from creation to access, search, review, approval and publication

Automate manual processes
with CARA workflows

Easily navigate and search content
CARA provides multiple ways to access the information you need

Securely access content on the go
our mobile apps give you the full CARA experience

Securely share information with external partners
secure third-party access, watermarking and more

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